Q.01

How do I search the FDA MAUDE database?

You can search MAUDE on FDA's public form at the MAUDE Database Search page, using either Simple or Advanced search. Both return at most 500 reports, so for anything larger you download FDA's MDR data files. I can also search a copy of the MAUDE bulk files for you here.

Approach: I opened FDA's MAUDE search form and its "About MAUDE" page, and searched the copy of the MAUDE bulk files that I can query.

1. Simple search (search form)

  • You can enter single words, an exact phrase in quotes, or several terms joined with "and". You can also search by UDI and pick a year.
  • It returns up to 500 results.

2. Advanced search (same page). You can filter on:

  • Product Problem, Product Class, Event Type (Death, Serious Injury, Malfunction, Other, No Answer Provided)
  • Manufacturer, Brand Name, Model Number
  • Product Code, PMA/510(k) Number, Report Number, Exemption Number, UDI-Device Identifier, Summary Report (Yes/No)
  • Date Report Received (a date range)
  • Results show 5 to 100 per page. FDA says it "will return up to 500 results for MDRs received over the selected timeframe."

Searching by product code is usually the most reliable way to capture a whole device type. The Product Classification Database, linked from FDA's MAUDE page, gives you that code.

3. Coverage and updates (About MAUDE)

  • The online search "contains the last ten years of MDR data." It is updated monthly with reports received up to the last day of the previous month.
  • For older reports or larger pulls, use the MDR Data Files page. Its zipped downloads cover voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993 and manufacturer reports since August 1996.

4. How FDA says to read the data (same page)

  • MDR data "is not intended to be used either to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices."
  • "The submission of an MDR itself does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event."
  • FDA also notes underreporting, inaccurate reports, unverified causality and unknown device usage. These limits matter if you use MAUDE for trending or a competitor safety review.

5. Searching through me I can search the MAUDE bulk files by MDR report key, report number, manufacturer name, event type, event location and report source, plus free text. Each record gives the event type, date received, report source and type of report (preliminary or final). For example, I found 1996 death reports listing manufacturers BOEHMANN [1] and BAYER [2].

The records I pulled had no device names or event descriptions. A search for "insulin pump" or "infusion pump" found only one 1996 report, matched on "pump" in the manufacturer field alone [3]. For searches by device type or brand, FDA's Advanced search (by product code or brand name) is the better tool.

If you give me a manufacturer, report number or event type, I can pull the matching reports.

Q.02

What can MAUDE reports tell me about device safety?

MAUDE reports are a signal source. They tell you that someone reported a death, serious injury or malfunction involving a device, and what they described. They cannot tell you how often events happen, whether the device caused them, or whether one device is safer than another. FDA says MDR data "is not intended to be used either to evaluate rates of adverse events... or to compare adverse event occurrence rates" (About MAUDE).

Approach: I looked at the copy of the MAUDE bulk files I can search to see which safety fields each report carries, and read FDA's About MAUDE and Medical Device Reporting (MDR) pages. Searches of the copy by event type (death, injury, malfunction) did not finish this time, so I couldn't pull example reports for each category.

What a MAUDE report can tell you

  • That an event was reported, and what kind it was. Manufacturers must report when a device "may have caused or contributed to a death or serious injury." They must also report a malfunction that would be likely to cause or contribute to death or serious injury if it happened again (MDR overview).
    • Importers report deaths and serious injuries to FDA and the manufacturer, and malfunctions only to the manufacturer.
    • User facilities report suspected device-related deaths to FDA and the manufacturer. They report serious injuries to the manufacturer, or to FDA if the manufacturer is unknown.
  • Whether the report is about patient harm or a device problem. Each record in the bulk files flags these separately. For example, a 2022 manufacturer report is flagged "Adverse event: N | Product problem: Y" [4]. Older reports can have uncoded fields: a 1995 report shows "Product problem: *" [5].
  • Who reported it. Each record carries a report source code and a type-of-report code [5]. Voluntary reports from patients, clinicians and caregivers cover "serious adverse events... use errors, product quality issues, and therapeutic failures" (MDR overview). The voluntary reports can show use errors and real-world use problems that manufacturer reports may not.
  • Qualitative patterns. The narrative descriptions and FDA's MDR adverse event codes let you group failure modes and patient effects by product code or brand. That makes MAUDE useful for hazard identification in a risk file, for postmarket surveillance trend reviews, and for benchmarking failure modes against similar devices.

What it cannot tell you (About MAUDE)

  • Causation: "The submission of an MDR itself does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event."
  • Incidence or prevalence: these "cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event."
  • Rates, trends or comparisons: MAUDE gives you no denominator (units in use), so a rise in report counts may mean more units in use, more awareness or reporting changes, not a drop in safety.
  • Full detail: confidential business information is redacted as "(b)(4)" and personal information as "(b)(6)."

How FDA uses the reports FDA reviews all reports "in context with all other relevant medical device information" as part of postmarket surveillance and signal detection. MDRs are "only one of the FDA's several important postmarket surveillance data sources" (About MAUDE). Treat a MAUDE finding the same way, as a reason to look further.

If you give me a manufacturer or report numbers, I can pull the matching MAUDE records and their event and product-problem flags.

Q.03